Insmed Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update

Recent Pillar Highlights

Pillar 1: ARIKAYCE

• ARIKAYCE global revenue grew 24% in 2023 compared to 2022, reflecting continued strong growth in the U.S., Japan, and Europe.
• Insmed received encouraging written feedback in December 2023 from the U.S. Food and Drug Administration (FDA) on the patient-reported outcome data produced in the Phase 3 ARISE study. The Company expects to meet with the FDA in the coming months to gain additional insights and guidance, from which it will finalize its statistical plan for the Phase 3 ENCORE study.
• As previously communicated in January 2024, the Company achieved its original target enrollment goal of 250 patients in the ENCORE trial in patients with newly diagnosed or recurrent nontuberculous mycobacterial lung infection caused by Mycobacterium avium complex (MAC) who had not started antibiotics. Enrollment in the trial remains open.
• The Data Safety Monitoring Committee for the ENCORE study held its third safety review meeting in November 2023 and recommended that the study continue as planned.
• Consistent with the Company's expectations, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan recently confirmed that it would not consider a label expansion for ARIKAYCE based on data from the ARISE study alone due to (i) the lack of Japanese subjects in that study; (ii) the absence of what PMDA considers a sufficiently long treatment exposure (12 months); and (iii) the absence of resulting evidence of culture conversion the PMDA considers durable (15 months). The ongoing ENCORE trial is designed to satisfy the PMDA's remaining regulatory requirements, including the enrollment of Japanese patients, sufficient treatment exposure, and an endpoint for durable culture conversion.
• The Company continues to expect topline data for ENCORE in 2025.

Pillar 2: Brensocatib

• Insmed continues to expect topline data from the Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis in the latter part of the second quarter of 2024.
• If ASPEN is successful and regulatory approval is obtained, the Company anticipates a launch in bronchiectasis in the U.S. in mid-2025, followed by launches in Europe and Japan in the first half of 2026. Insmed continues to advance its launch readiness activities in preparation for these potential launches.
• The Data Safety Monitoring Committee for the ASPEN study held its fifth and final meeting in November 2023. No safety signals were identified, and the Committee recommended that the trial continue as planned.
• The Company is currently enrolling patients in the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP).
• The Company expects to initiate a Phase 2 study of brensocatib in patients with hidradenitis suppurativa (HS) in the second half of 2024, pending positive results from the ASPEN study.

Pillar 3: TPIP

• In October 2023, Insmed announced encouraging blended and blinded data from two ongoing Phase 2 studies of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).
• The Company completed enrollment of 39 patients in the Phase 2 safety study in PH-ILD in November 2023, exceeding its initial enrollment target of 32 patients. Topline data from the study are anticipated in advance of Phase 3 ASPEN data in the second quarter of 2024.
• Enrollment remains ongoing in the Phase 2 study in PAH. Insmed anticipates sharing updated blinded data from approximately 40 patients in the PAH study at the same time topline results from the PH-ILD study become available in the second quarter of 2024. Topline results from the Phase 2 PAH study continue to be expected in 2025.
• Insmed has submitted a protocol amendment to the FDA and other regulatory authorities for the open-label extension of the Phase 2 PAH study. This amendment, if approved, would allow investigators to continue to increase the dose of TPIP up to a maximum of 1,280 micrograms once daily.

Pillar 4: Early-Stage Research

• Insmed's early-stage research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies.
• The Company continues to anticipate the totality of its early-stage research programs will comprise less than 20% of overall annual spend.

Fourth-Quarter and Full-Year 2023 Financial Results

• Total revenue for the fourth quarter ended December 31, 2023, was $83.7 million, reflecting 41% growth compared to total revenue of $59.3 million for the fourth quarter of 2022. Total revenue for the full-year 2023 was $305.2 million, compared to total revenue of $245.4 million for the full-year 2022, reflecting 24% year-over-year growth.
• Total revenue for the full-year 2023 was comprised of ARIKAYCE net sales of $224.2 million in the U.S., $65.7 million in Japan, and $15.3 million in Europe and rest of world. Full-year 2023 sales demonstrated year-over-year growth of 21% in the U.S. and 16% in Japan, reflecting continued strong growth trends for ARIKAYCE in these regions.
• Cost of product revenues (excluding amortization of intangibles) was $18.4 million for the fourth quarter of 2023, compared to $13.1 million for the fourth quarter of 2022, primarily reflecting the increase in sales volumes. For the full-year 2023, cost of product revenues (excluding amortization of intangibles) was $65.6 million compared to $55.1 million for the full-year 2022.
• Research and development (R&D) expenses were $137.0 million for the fourth quarter of 2023, compared to $124.8 million for the fourth quarter of 2022. For the full-year 2023, R&D expenses were $571.0 million compared to $397.5 million in 2022, reflecting one-time, non-cash asset acquisition costs and the continued investment in Insmed's early and mid- to late-stage pipeline programs, including increases in headcount to support those existing and acquired programs.
• Selling, general and administrative (SG&A) expenses for the fourth quarter of 2023 were $89.5 million, compared to $73.5 million for the fourth quarter of 2022. For the full-year 2023, SG&A expenses were $344.5 million, compared to $265.8 million for the full-year 2022. The year-over-year increase in SG&A expenses resulted primarily from commercial readiness activities for brensocatib and an increase in headcount.
• For the fourth-quarter 2023, Insmed reported a net loss of $186.1 million, or $1.28 per share, compared to a net loss of $160.1 million, or $1.21 per share, for the fourth-quarter 2022. For the full-year 2023, Insmed reported a net loss of $749.6 million, or $5.34 per share, compared to a net loss of $481.5 million, or $3.91 per share, for the full-year 2022.

Balance Sheet, Financial Guidance, and Planned Investments

• As of December 31, 2023, Insmed had cash, cash equivalents, and marketable securities totaling $780.4 million.
• Insmed is reiterating its sales guidance for full-year 2024 global ARIKAYCE revenues in the range of $340 million to $360 million, representing 15% year-over-year growth at the midpoint compared to 2023.
• Insmed continues to anticipate that over 80% of total annual expenditures will be on its mid- to late-stage and commercial programs (ARIKAYCE, brensocatib, and TPIP), and that less than 20% of overall spend will be on its early-stage research programs, reflecting the Company's historical approach to spending.
• The Company plans to continue to invest in the following key activities in 2024:

(i) commercialization and expansion of ARIKAYCE globally;

(ii) advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis, and commercial launch readiness activities, the ongoing Phase 2 trial in patients with CRSsNP, and the Phase 2 program in HS to be initiated in the second half of the year if the ASPEN result is positive;

(iii) advancement of the clinical trial program for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung infection;

(iv) advancement of its Phase 2 clinical development programs for TPIP; and

(v) development of its early-stage research programs.

Conference Call

Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company's website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through March 23, 2024, by dialing (800) 770-2030 (U.S. and international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.

INSMED INCORPORATED
Consolidated Statements of Net Loss
(in thousands, except per share data)
(unaudited)
	Three Months Ended December 31,				Twelve Months Ended December 31,
	2023		2022		2023		2022
Product revenues, net	$      83,693		$      59,300		$    305,208		$    245,358
Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)	18,443		13,069		65,573		55,126
Research and development	137,029		124,763		571,011		397,518
Selling, general and administrative	89,530		73,479		344,501		265,784
Amortization of intangible assets	1,263		1,264		5,052		5,053
Change in fair value of deferred and contingent consideration liabilities	15,700		(1,800)		28,697		(20,802)
Total operating expenses	261,965		210,775		1,014,834		702,679
Operating loss	(178,272)		(151,475)		(709,626)		(457,321)
Investment income	9,853		8,318		42,132		11,081
Interest expense	(20,784)		(16,445)		(81,694)		(26,446)
Change in fair value of interest rate swap	1,970		(1,526)		320		(1,526)
Other income (expense), net	2,170		1,130		1,856		(5,939)
Loss before income taxes	(185,063)		(159,998)		(747,012)		(480,151) Werbung Mehr Nachrichten zur Insmed Inc Aktie kostenlos abonnieren E-Mail-Adresse Bitte überprüfe deine die E-Mail-Adresse. Benachrichtigungen von ARIVA.DE (Mit der Bestellung akzeptierst du die Datenschutzhinweise) -1 Vielen Dank, dass du dich für unseren Newsletter angemeldet hast. Du erhältst in Kürze eine E-Mail mit einem Aktivierungslink. Hinweis: ARIVA.DE veröffentlicht in dieser Rubrik Analysen, Kolumnen und Nachrichten aus verschiedenen Quellen. Die ARIVA.DE AG ist nicht verantwortlich für Inhalte, die erkennbar von Dritten in den „News“-Bereich dieser Webseite eingestellt worden sind, und macht sich diese nicht zu Eigen. Diese Inhalte sind insbesondere durch eine entsprechende „von“-Kennzeichnung unterhalb der Artikelüberschrift und/oder durch den Link „Um den vollständigen Artikel zu lesen, klicken Sie bitte hier.“ erkennbar; verantwortlich für diese Inhalte ist allein der genannte Dritte. Andere Nutzer interessierten sich auch für folgende News 01.05.24 - Carsten Ringler Paukenschlag in USA: Cannabis-Neuregulierung durch DEA sorgt für Kursexplosion! 01.05.24 - PR Newswire Invesco Bond Income Plus Ltd - Portfolio Update 01.05.24 - PR Newswire Third Point Investors Ltd - Third Point Releases Q1 2024 Investor Letter Paukenschlag in USA    Cannabis-Neuregulierung durch DEA sorgt für Kursexplosion! weiterlesen» Anzeige wo-site-teaser-box-16809_site-teaser-box_2024-05-01_09%253A00%253A00_2024-05-02_09%253A00%253A59